OXFORD BIOMEDICA GETS SPA FOR RENAL CANCER STUDY

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Oxford BioMedica has received a special protocol assessment (SPA) agreement from the FDA for a Phase III trial of TroVax in renal cell carcinoma. The agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which, if successful, will support an efficacy claim in a regulatory submission for product registration.

The Phase III trial, referred to as TRIST (TroVax Renal Immunotherapy Survival Trial), will evaluate whether TroVax immunotherapy, added to first line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma.